FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPUS CHP-P10 NEPHROSCOPE/CYSTOSCOPE
K Number: K843084
·
Decision Jan 3, 1985
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
18
Applicant Total
142
Review Days
150
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Basic Information
- Device Name
- OLYMPUS CHP-P10 NEPHROSCOPE/CYSTOSCOPE
- K Number
- K843084
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Olympus Corp.
- Date Received
- August 6, 1984
- Decision Date
- January 3, 1985
- Product Code
- FBO
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FBO | Cystourethroscope | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FBO), ordered by most recent decision date.
KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)
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FDA Class 2
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KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)
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FDA Class 2
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FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE
FDA 510(k)
FDA Class 2
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KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ANCHORAGE SCOPE, MODEL 000003
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Olympus Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K915402 | EW-10 AND EW-20 | Jun 23, 1995 | Substantially Equivalent for Some Indications |
| K933200 | OLYMPUS PBD STENTS | Apr 5, 1995 | Substantially Equivalent |
| K942338 | OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES | Nov 30, 1994 | Substantially Equivalent |
| K931763 | HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS | Aug 29, 1994 | Substantially Equivalent |
| K934835 | FLOVAL | Jun 21, 1994 | Substantially Equivalent |
| K931764 | HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES | Jun 8, 1994 | Substantially Equivalent |
| K915857 | FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE | Mar 11, 1994 | Substantially Equivalent |
| K931994 | RESECTOSCOPE SHEATH | Feb 17, 1994 | Substantially Equivalent |
| K933992 | OLYMPUS SCLEROTHERAPY BALLOON | Dec 21, 1993 | Substantially Equivalent |
| K934361 | OLYMPUS CREATININE REAGENT | Nov 16, 1993 | Substantially Equivalent |